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NCT Number: NCT04548973

A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section

This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

  • case selection: A total of 600 patients (American Society of Anesthesiologists (ASA) grade I-II, aged 20-40 years,BMI 18.5-27) who underwent elective cesarean section were selected.
  • anesthesia methods: All patients were not given preoperative medication. After entering the operating room, peripheral venous connection was opened. Mindray multifunctional vital sign monitor continuously monitored electrocardiogram (ECG), heart rate (HR), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP) and Mean arterial pressure (MAP). After 5 minutes of waiting for patients with no obvious discomfort, 0.75% of ropivacaine was given 10ml before catheterization, and 0.75% of ropivacaine 3-5ml per hour maintained anesthesia
  • Grouping methods: A random number table was used to divide the patients into two groups with 300 patients in each group: The Esketamine group (group A) and the control group (group B) Esketamine group (Group A): at the beginning of the operation, 0.25mg/kg(2ml) Esketamine was administered intravenously as an adjuvant sedation and analgesia;Control group (Group B): 2ml normal saline was given intravenously at the beginning of the operation;
  • Observation items and methods 4.1 Forty patients were randomly selected from the Estroketamine group (group A) to detect the serum concentrations of Esketamine in umbilical vein blood and umbilical artery blood of neonates during fetal delivery.

4.2 maternal hemodynamic indexes such as heart rate (HR), mean arterial pressure (MAP) and respiratory mechanics indexes such as pulse oxygen saturation (SpO2) and shout at the end of the co2 partial pressure (PaCO2) are measured before anesthesia surgery at the beginning of the fetal childbirth at the end of the operation and operation after 1 hour when recording and compare the two groups of 4.3 maternal visual analog pain score (VAS) and sedation scores (Ramsay) and the time from uterine incision to fetal childbirth are measured before anesthesia surgery at the beginning of the fetal childbirthAt the end of the operation and operation after 1 hour record and compare the two groups of 4.4 respiratory system complications within 72 h in pregnant women (hypotension sinus bradycardia nausea and vomiting respiratory depression) are record.

4.5 Apgar score 1, 5, 10 minutes after birth, umbilical arterial blood gas and neurobehavioral scores (NBNA) 2 and 24 hours after the birth are record.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • full-term single pregnancy
  • had regular prenatal examination
  • scheduled for elective cesarean delivery with epidural anesthesia

Exclusion criteria

  • body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater
  • previous mental illness, central nervous system disease, liver disease, abnormal kidney function, abnormal heart and lung function, diabetes, or American Society of Anesthesiologists (ASA) classification III or above
  • severe obstetric complications, such as preeclampsia and eclampsia, pregnancy-induced hypertension, placenta previa, or placental abruption
  • stillbirth or neonatal malformation
  • contraindications to epidural anesthesia, including abnormal coagulation function, anticoagulant therapy, severe hypovolemia, or hemodynamic instability

Treatment and study plan

Esketamine

Drug

Esketamine

normal saline

Drug

2ml normal saline

Primary outcomes

  1. Maternal pain intensity

    Time frame: immediately after fetal delivery

    Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)

  2. Maternal sedation level

    Time frame: immediately after fetal delivery

    Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)

Secondary outcomes

  1. Maternal pain intensity at other timepoints

    Time frame: before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,

    Maternal pain intensity at other timepoints were assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)

  2. Maternal sedation level at other timepoints

    Time frame: before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,

    Maternal sedation level at other timepoints were assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)

  3. systolic blood pressure, diastolic blood pressure, and mean blood pressure

    Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

    systolic and diastolic blood pressure were assessed by non-invasive blood pressure cuff,mean blood pressure was measured by the Calculation formula: Mean arterial pressure =(systolic pressure +2× diastolic pressure)/3

  4. maternal heart rate

    Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

    maternal heart rate

  5. pulse oxygen saturation

    Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

    pulse oxygen saturation

  6. Apgar score of newborn

    Time frame: at 1 minute and 5 minute after birth

    Apgar was assessed by appearance, pulse, grimace, activity, respiration. Each item was measured on a scale of 0, 1, and 2, respectively, with a maximum total score of 10.

  7. postnatal umbilical vein blood gas pH value

    Time frame: Results of umbilical arterial blood gas analysis after birth

    postnatal umbilical vein blood gas pH value

  8. Esketamine concentrations in maternal arterial blood and neonatal umbilical arterial

    Time frame: Immediately after fetal delivery

    Esketamine concentrations was assessed by reverse-phase high-performance liquid chromatography

Other outcomes

  1. Adverse events including hypotension, hypertension, bradycardia, tachycardia and desaturation

    Time frame: Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery

    hypotension was defined as a systolic blood pressure decrease less than 20% of baseline, hypertension was defined as a systolic blood pressure increase greater than 20% of baseline, bradycardia was defined as a heart rate less than 60 beats per minute, tachycardia was defined as a heart rate greater than 100 beats per minute, and desaturation was defined as oxygen saturation less than 90%.

  2. offspring's neurodevelopment

    Time frame: 2 years after birth

    Neurodevelopment was measured by the Ages and Stages Questionnaire, third edition (ASQ-3).The ASQ-3 assesses 5 developmental domains: gross motor skills, fine motor skills, problem-solving ability, communication, and personal and social skills. Each domain is assessed by 6 questions ascertaining achievement of relevant skills and answered as yes (10 points), sometimes (5 points), or not yet (0 points). Scores for individual items are summed to give an overall continuous score for each of the 5 domains (possible range, 0-60).

  3. Mothers' memories of childbirth

    Time frame: at 2 years after birth

    Mothers' memories of childbirth was assessed by The Birth Memories and Recall Questionnaire (BirthMARQ),which focused on parents' positive, negative or mixed emotions at the birth/in recalling the event. Each item (e.g. 'my emotions at the time were extremely negative') was rated on a scale ranging from 1 (strongly disagree) to 7 (strongly agree).

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study title

A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.